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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ureteroscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To perform various diagnostic and therapeutic procedures within the urinary tract.
Product CodeFGB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 8
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No display or display failure 12
Break 9
No Known Device Problem 5
Leak 4
Mechanical issue 3
Device or device component damaged by another device 3
Improper device output 2
Material Protrusion 2
Peeled 2
Detachment of device component 2
Incorrect display 2
False device output 2
Fluid leak 1
Material frayed 1
Heat 1
Hole in material 1
Difficult to insert 1
Kinked 1
Entrapment of device or device component 1
Material disintegration 1
Material puncture 1
Material separation 1
Material perforation 1
Cut in material 1
Physical resistance 1
Device operates differently than expected 1
Misfocusing 1
Poor quality image 1
Normal 1
Material deformation 1
Optical issue 1
Total Device Problems 67

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Pentax Medical Company II Jun-28-2016

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